MENTOR MemoryGel Breast Implant 3545455Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00081317007166), received between Nov 7, 2019 and Mar 21, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 455CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS RUPTURED DURING A BREAST SURGERY AT THE TIME OF IMPLANTATION. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO ADVERSE EVENTS OR PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665361 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 455CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY FOR UNSPECIFIED REASONS ON (B)(6) 2024. MULTIPLE FOLLOW-UPS WERE PERFORMED BUT NO CLARIFYING INFORMATION WAS RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN INFORMATION IS MADE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20258037 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL , 455CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE II-III POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 19919870 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORY GEL , 455CC SILICONE PROSTHESIS. EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, GRADE II-III POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 19919659 ↗
• InjuryDec 7, 2023Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 455CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18283871 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 455CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING INFLAMMATION FROM THE ARM TO THE KNEES, TO THE FEET, THEN TO THE HANDS. BLOOD TEST RESULTS INDICATED INCREASED AMA LEVELS. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. ADDITIONALLY, THE PATIENT DEVELOPED ASYMMETRY POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 17902332 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 455CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING INFLAMMATION FROM THE ARM TO THE KNEES, TO THE FEET, THEN TO THE HANDS. BLOOD TEST RESULTS INDICATED INCREASED AMA LEVELS. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. ADDITIONALLY, THE PATIENT DEVELOPED ASYMMETRY POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement

  MAUDE report 17902330 ↗
• InjuryApr 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 455CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION AND MAMMOGRAM, WITH RIGHT BREAST IMPLANT RUPTURE AND SILICONE OUTSIDE THE BREAST TISSUE. THE RIGHT BREAST ALSO HAD PAIN. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2022. DURING THE REVISION SURGERY, IT WAS DISCOVERED THAT THE LEFT IMPLANT WAS ALSO RUPTURED. SUBSEQUENTLY, BOTH IMPLANTS WERE REMOVED AND REPLACED WITH TWO 480CC MENTOR ULTRA HIGH SMOOTH IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Swollen Lymph Nodes/Glands

  MAUDE report 14048602 ↗
• InjuryApr 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 455CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION AND MAMMOGRAM, WITH RIGHT BREAST IMPLANT RUPTURE AND SILICONE OUTSIDE THE BREAST TISSUE. THE RIGHT BREAST ALSO HAD PAIN. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2022. DURING THE REVISION SURGERY, IT WAS DISCOVERED THAT THE LEFT IMPLANT WAS ALSO RUPTURED. SUBSEQUENTLY, BOTH IMPLANTS WERE REMOVED AND REPLACED WITH TWO 480CC MENTOR ULTRA HIGH SMOOTH IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14048601 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A (B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF BASAL SKIN CANCER (2019) AND HYSTERECTOMY (2012) WHO UNDERWENT BREAST IMPLANT REVISION SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANTS (SILTEX ULTRA HIGH PROFILE) (PRODUCT CODE: 3545455/LOT NUMBERS: 6639373-RIGHT & 6934350-LEFT) ON (B)(6) 2017 AND WAS DIAGNOSED WITH RIGHT-SIDED BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL) ON (B)(6) 2021. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION OF THE TEXTURED IMPLANTS AND REPLACEMENT WITH SMOOTH IMPLANTS ON (B)(6) 2021. IN THE YEAR OF 1998, THE PATIENT HAD COSMETIC BREAST AUGMENTATION WITH 300CC SALINE TEAR-DROP SHAPED IMPLANTS (SUBPECTORAL PLACEMENT). INFORMATION REGARDING BRAND/MANUFACTURER AND THE EXACT DATE OF IMPLANT IS UNKNOWN, HOWEVER THE DEVICES WERE NOT MENTOR PRODUCTS. ON (B)(6) 2012, THE PATIENT UNDERWENT CRESCENT MASTOPEXY AND UPPER BLEPHAROPLASTY. THEN, ON (B)(6) 2012, THE PATIENT HAD A RIGHT NIPPLE-AREOLA COMPLEX (NAC) REVISION. ON (B)(6) 2016, THE PATIENT SUFFERED FROM MEDIAL DISPLACEMENT OF HER LEFT BREAST IMPLANT AFTER A MOTOR VEHICLE ACCIDENT WITH STERNAL TRAUMA. EXAMINATION REVEALED THIN TISSUES WITH D

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Seroma

  MAUDE report 12701088 ↗
• InjuryJul 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 455 CC AND SUFFERED FROM RUPTURE ON THE RIGHT SIDE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10236559 ↗
• InjuryJan 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A 455CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE LEFT-SIDED RUPTURE AND BILATERAL PSEUDOPTOSIS, CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 400CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG # 3504004BC, LEFT SERIAL # (B)(4) AND RIGHT SERIAL # (B)(4) ON (B)(6) 2019. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT. REFER TO MANUFACTURER REPORT NUMBER 1645337-2019-23350 FOR REPORT ON THE CONTRALATERAL DEVICE.

  Patient problems: No Code Available

  MAUDE report 9630457 ↗
• InjuryNov 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A 455CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED RUPTURE, CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 400CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG # 3504004BC, LEFT SERIAL # (B)(4) AND RIGHT SERIAL # (B)(4) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9292858 ↗